Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202308689414142 Date of Approval: 04/08/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of preoperative vaginal preparation with 0.3% chlorhexidine-cetrimide versus 10% povidone-iodine on post cesarean section infection in obstetric care facility in Lagos
Official scientific title Effect of preoperative vaginal preparation with 0.3% chlorhexidine-cetrimide versus 10% povidone-iodine on post cesarean section infection.
Brief summary describing the background and objectives of the trial Caesarean section is one of the commonly performed surgical procedures in obstetrics and certainly one of the oldest operations in surgery; the incidence of caesarean section has steadily risen over time. The increasing use of caesarean section as a mode of delivery is due to improved safety of the procedure, appropriate use of antibiotics, blood availability, and improved anaesthetic techniques. Despite all the advances for safety, infectious morbidity after cesarean delivery still complicates the procedure and can have a tremendous impact on the postpartum woman’s ability to return to normal function and her ability to care for her baby. Globally, the procedure is widely embraced and utilized but additional challenges in the developing regions include aversion, misconception, guilt and fear surrounds the procedure especially in Nigeria. Infectious morbidity is the most frequent complication of cesarean delivery. Of women who have cesarean sections, 5–24% have clinically significant fevers; 6 –21% are diagnosed with uterine infections (endomyometritis or endometritis), 1–5% with more extensive pelvic infections including abscesses and 2–9% with breakdown of the surgical incision1. Death from infectious complications is rare, with an incidence of six deaths per 100,000 cesarean delivery. OBJECTIVE To determine the effects of vaginal pre-operative Chlorhexidine-gluconate solution to that of Povidone-Iodine in the prevention of post-caesarean infectious morbidities
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied SURGICAL SITE INFECTIONS, ENDOMETRITIS AND ENDOMYOMETRITIS
Purpose of the trial Prevention
Anticipated trial start date 01/08/2023
Actual trial start date 01/09/2023
Anticipated date of last follow up 01/12/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 250
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group CHLOROHEXIDINE GROUP 0.3% Chlorhexidine- 3% Cetrimide solution 30 SECONDS Participants in the Chlorhexidine arm had routine vulva cleansing with Chlorhexidine and urethral catheterization, thereafter have the intervention of vaginal cleansing with 0.3% Chlorhexidine- 3% Cetrimide solution. The vagina cleansing would be done using a single piece of 5x5cm sterile gauze saturated with Chlorhexidine for about 30seconds. The cleansing is done circularly once. Thereafter, the patient returns to the supine position with right lateral wedge. The topmost gloves would be changed prior to performing the abdominal scrub. 125 Active-Treatment of Control Group
Experimental Group POVIDONE IODINE 10% POVIDONE IODINE 30 SECONDS Participants in the povidone arm had routine vulva cleansing with povidone and urethral catheterization, thereafter have the intervention of vaginal cleansing with 10% povidone iodine solution. The vagina cleansing would be done using a single piece of 5x5cm sterile gauze saturated with povidone for about 30 seconds. The cleansing is done circularly once. Thereafter, the patient returns to the supine position with right lateral wedge. The topmost gloves would be changed prior to performing the abdominal scrub. 125
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Ages eligible for study: ≥18 years - All pregnant women with gestational age of 28 weeks and above. - Pregnant women with indication for emergency or elective Cesarean section. - Patient must give informed consent. - Allergy/Contraindications to either Povidone-Iodine (thyroid disease) and Chlorhexidine - Obstructed Labour - Active genital herpes - Face Presentation - Antepartum hemorrhage, cord prolapse with life fetus - Active Chorioamnionitis, - Women on chronic steroid use, Diabetes Mellitus, HIV infection, - Intrauterine Fetal Death - Evidence of pre-operative skin infection - Women considered for a hysterectomy at the time a decision for Cesarean section was made were also excluded. Adult: 19 Year-44 Year 18 Year(s) 44 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 17/07/2023 FEDERAL MEDICAL CENTRE ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
RAILWAY COMPOUND EBUTE METTA LAGOS 101212 Nigeria
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 16/08/2023 HEALTH SERVICE COMMISSION
Ethics Committee Address
Street address City Postal code Country
1 GANIYU SMITH STREET LAGOS ISLAND LAGOS 102273 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome to be measured is the difference between the incidence of post-caesarean section composite infectious morbidities between participants on preoperative vaginal cleansing with Chlorhexidine solution and those on preoperative vaginal cleansing with Povidone-iodine. 48 hours post-operatively up to 6 weeks post-partum
Secondary Outcome 1. Incidence of post-operative endometritis in respective study groups. 2. Incidence of post-operative febrile morbidities in respective study groups. 3. Incidence of post-operative wound infections in respective study groups. 4. The frequency of patient-reported vaginal symptoms (dryness, burning, itchiness, unusual vaginal discharge, pain or burning with urination) with Chlorhexidine or Povidone-Iodine vaginal cleansing in respective study groups. 5. The bacteriological aetiology for SSI following caesarean section and their antimicrobial susceptibility patterns in respective study groups. 6. Neonatal 1st & 5 minutes APGAR score (fetal outcome) after treatment with Chlorhexidine or Povidone-Iodine vaginal cleansing in respective study groups 48 hours post operatively up to 6 weeks post partum
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
FEDERAL MEDICAL CENTRE EBUTE METTA RAILWAY COMPOUND EBUTE METTA LAGOS 101212 Nigeria
RANDLE GENERAL HOSPITAL HAKEEM HABEEB CLOSE SURULERE LAGOS 101241 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
OHIOMOBA GLADYS RAILWAY COMPOUND EBUTE METTA LAGOS 101212 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor OHIOMOBA GLADYS RAILWAY COMPOUND EBUTE METTA LAGOS 101212 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator FUNMILOLA ARIBISALA funmihelenaribs@gmail.com +2347032604468 RAILWAY COMPOUND EBUTE METTA
City Postal code Country Position/Affiliation
LAGOS 101212 Nigeria COLLEAGUE
Role Name Email Phone Street address
Public Enquiries OLUWAKEMI WINDAPO bolawindapo@gmail.com +2348023099282 RAILWAY COMPOUND EBUTE METTA
City Postal code Country Position/Affiliation
LAGOS 101212 Nigeria COLLEAGUE
Role Name Email Phone Street address
Scientific Enquiries ADERONKE OPADERE aderonkeopadere@gmail.com +2348062096446 RAILWAY COMPOUND EBUTE METTA
City Postal code Country Position/Affiliation
LAGOS 101212 Nigeria COLLEAGUE
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes In this study, I, the principal investigator intends to share my findings in accordance with basic ethical principles. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared beginning 9 months and ending 36 months following article publication of study completion. With data Researchers who provide a methodologically sound proposal. Other documents that would be made available includes Study Protocol. The mechanism by which it would be made available indefinitely is by a provided link. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol within 15 months after completion of study Researchers who provide a methodologically sound proposal.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information